Medical Device Quality Control & Manufacturing Solutions
To stay competitive in the medical device market, companies should focus on niche areas like personalized and miniaturized devices for aging patients. New technologies, such as 100% resorbable bio-ceramics and autologous cell-based bone substitutes, must ensure long-term biocompatibility, safety, and functionality. In-process quality control tests are crucial to verify product quality and specifications at every stage of production.
Sartorius offers smart and robust solutions for medical device quality control, including testing for correct dose delivery, moisture content, sterility, and ultrapure dialysis fluid.
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Final packaging materials can vary in characteristics and hygroscopic properties. However, they need a specific moisture content for optimal processing and to assure appearance and functionality of the final product.
Membrane filtration solutions for standard microbial enumeration protocols per USP <61> facilitate an efficient, accurate detection of potentially pathogenic or spoilage microorganisms.
Explore pump testing solutions for precise drug delivery, ensuring medical device accuracy and compliance.
Assessing composition of materials and their ability to release extractables and leachables is standard in biological evaluation per ISO 10993. FTIR, MS, ICP-MS or GC require robust, reliable sample preparation and streamlined workflows to ensure clean, reproducible, interference-free results.
Measure density, count small pieces, check coating or control correct assembly in packaging accurately and with full regulatory compliance.
Raw and packaging materials can vary in characteristics and hygroscopic properties. However, they need a specific moisture content for optimal processing and to assure appearance and functionality of the final product.
Solutions designed for capturing particulate matter, reliable optical analysis and accurate quantification.
Continuous monitoring is a must to evaluate the microbial flora at your manufacturing facility for deviations from norm or to detect undesirable organisms.
Guaranteeing a specified density of raw materials in coatings, 3D inks, plastics, and metals is crucial for stability and safety of drug delivery systems. Deviations due to impurities or poor quality may have profound effects on the final product.
Assessing composition of materials and their ability to release extractables and leachables is standard in biological evaluation per ISO 10993. FTIR, MS, ICP-MS or GC require robust, reliable sample preparation and streamlined workflows to ensure clean, reproducible and interference-free results.
Biological response to medical devices depends on their constitutive components and classification.
ISO 10993-5 assesses in vitro cytotoxicity and is designed to determine the biological response of cultured cells in contact with a device and/or its extracts.
ISO 10993-18 allows identification of chemical substances released under clinical conditions of use.
Weighing solutions to define the optimal dose of Active Pharmaceutical Ingredient (API) to be applied on an integral implantable device, such as a drug eluting stent (DES).
Prior to evaluating reference values, like conjugation or encapsulation efficiency, zeta potential and size distribution, successful purification and concentration of the suspension or dispersion is essential.
Precision weighing balances for drug eluting stents for accurate, reliable results and increased productivity
Build on a reliable partnership with customized solutions tailored to your individual requirements
Efficient, reliable, user-friendly microbiological testing solutions for medical devices
Analytical solutions to meet the increasing QC requirements of global regulatory agencies
Accurate and compliant solutions for flow rate and bolus assessment
Precision Analytical Balances for Drug Delivery Systems for Accurate, Reliable Results and Increased Productivity
The Cubis® II analytical balance is designed for high-performance weighing and offers digital workflow management following US FDA data integrity principles (ALCOA). On-board QApps contribute to correct usage by guiding users through weighing processes, increasing measurement accuracy, precision and process safety.
The Pharma Software Application Package supports compliance with FDA 21 CFR Part 11 and EU GMP Annex 11, USP Chapter 41 and includes features like user management, digital signatures, audit trail and minimum sample weight determination.
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Efficient, Reliable, User-Friendly Microbiological Testing Solutions for Medical Devices
Choose total safety and convenience using Sartorius MD8 Airscan® technology. Collect samples using a single gelatin membrane filter, without interfering with zone protection.
Proprietary, USP-approved filters retain the smallest airborne microorganisms, practically ruling out false-negative results. Conveniently focus on other tasks, while your air sampler eliminates the need for manipulation or changing agar plates.
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To maximize lab space capabilities, your water system should adapt to your needs. Users need full control over quality parameters at the point of use and the ability to fill containers of different size at the same time.
The innovative, flexible Arium® Smart Station addresses these requirements. Dispense water in the exact quality and quantities required for your experiments, when and where you need it.
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Discover case studies specific to Medical drug Delivery Applications and read how Sartorius supports Medical Device manufacturers
State-of-the-art lab instrumentation with built-in applications and security settings:
Sartorius products are developed, produced, and distributed to ISO 9001 Quality Management System standards. They meet stringent quality control standards throughout all manufacturing steps and are backed by quality assurance certificates that guarantee conformity to specifications.
Lab balances connect seamlessly to user management systems generating traceable results. Software solutions support your documentation compliant to US FDA 21 CFR Part 11, EU GMP Annex 11 or ALCOA.
Optimize your process, identify important correlations or diagnose root causes of problems to significantly reduce experimental costs, de-risk projects and increase success rates. Achieve your quality goals and Quality by Design (QbD) requirements.
Our solutions enable precise and accurate testing, ensuring long-term biocompatibility, safety, and functionality of medical devices. With Sartorius, you can enhance your quality control processes and ensure compliance with industry standards. Find solutions for many applications below.
Sartorius provides advanced pump testing solutions tailored for the medical device industry, ensuring the precision and reliability of pumps used in critical applications.
Cubis® II balances, including the MCA66S micro balance and MCA225S semi-micro balance, are designed to meet rigorous industry standards such as AAMI TIR 101, IEC 60601-2-24, FDA, MDR, and GMP.
Key features and benefits include:
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Lab balances are indispensable instruments in the medical device industry. They are used at several stages of quality control to count large numbers of components based on individual weight, verify no part is missing, control deviations of purity in raw materials or optimize ceramic, plastic or pharmaceutical coatings.
Sartorius balances provide the weighing capacities needed by ensuring full traceability of data, time-saving workflows and accurate results.
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Compendium: Weighing Application Compendium Density Determination
Raw and packaging materials can vary in characteristics and hygroscopic properties. However, they need a specific moisture or solid content for optimal processing and to assure appearance and functionality of the final product. Current standards, such as the ASTMD1417-16 for determination of total solid content of latex, are critical for further processing of wearables, devices and personal protective equipment (PPE).
Sartorius offers robust and reliable MA160 Moisture Analyzers to detect and document moisture content quickly and easily within routine applications.
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Application Note: Fast and Precise Determination of Total Solid Content of Latex
ISO 10993-1 requests a safety evaluation and risk assessment to exclude potential harmful effects of constituent materials, as for nanomaterials. Prior to evaluating reference values, like conjugation or encapsulation efficiency, zeta potential and size distribution, successful purification and concentration of suspension or dispersion is essential. However, typical separation methods like size-exclusion chromatography and dialysis require subsequent concentration steps and extensive manual handling that is time-consuming and costly.
Sartorius Vivaspin® Lab Ultrafiltration devices move you one step ahead:
Application Note: An Improved Method to Wash Graphene Prior to Use as a Drug Delivery Vehicle
Biological response to medical devices depends on constitutive components and classification.
The biological risk of a system is often directly linked to its surface properties and material constituents. Assessing the composition of materials and their ability to release leachables and extractables (L&E) is standard in evaluating biocompatibility. FTIR, MS, ICP-MS or GC require robust, reliable sample preparation and streamlined workflows to ensure clean, reproducible, interference-free results.
Sartorius provides user-friendly sample prep tools for chemical characterization per ISO 10993-18. Time-saving solutions for preparing samples for content and purity analysis produces robust and reliable sample processing procedures.
Cytotoxicity testing is a standard biocompatibility test to evaluate toxicity levels or irritancy potential of the device or material. According to ISO 10993-5, the quantitative MTT Assay involves the incubation of cultured mammalian cells in contact with a device and/or extracts to determine biological response.
Incucyte® Cytotox Dyes, in combination with the Incucyte® Live-Cell Analysis System, kinetically measure dynamic changes in cell membrane integrity to quantify cytotoxicity over multiple days. The Incucyte® Cytotoxicity Assay provides real-time measurements of cell death in response to treatments, pharmacological agents or environmental factors and can be used to determine biocompatibility.
While not CFR 21-compliant, the Incucyte® Live-Cell Analysis System is ideal for research and development studies across multiple drug delivery applications.
Microbial contamination can be present in raw materials or introduced during production. To prevent biofilms and corrosion, cooling water for autoclaves or instruments for production, like welders or drills, must be free from bacterial contamination. Testing along manufacturing as per ISO 11737-1 is crucial to ensure product quality and patient safety. A knowledge of bioburden (population of viable microorganisms) is essential to validate the sterility assurance level (SAL) and monitor cleaning processes and raw materials.
Combining these controls with continuous air monitoring is part of the Contamination Control Strategy described in GMP Annex 1. Continuous monitoring is a must to evaluate microbial flora at manufacturing facilities for deviations from the norm or to detect undesirable organisms.
Sartorius Microsart @Filter units for standard microbial enumeration protocols per USP <61> or MD8 Air Sampler enable efficient and accurate detection of potentially pathogenic or spoilage microorganisms:
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Read the blog post: Somethin' Buggin' Ya? Get the Basics of Bioburden Testing
Cleanliness determination or rinsing of the device after manufacturing process requires highly purified water (DI, RO, EDI Ultrapure), which is deionized and free from impurities, like bacteria or particles. It feeds lab equipment like washing machines, steam sterilizers or autoclaves or flushes the device before particulate matter analysis.
Medical devices in direct contact with the patient must be scrupulously clean and free of interfering residues. According to VDI 2083 and ISO 14644-9, cleanliness can be assessed by guiding the flushing medium through filter membranes possessing an appropriate porosity for the particle size to be determined. The filters containing the particles are then dried and analyzed either gravimetrically or microscopically.
Sartorius’ Cellulose Nitrate Membranes offer precise surface capture and reliable optical analysis. Rinse your device with Sartorius Arium®️ Water Purification Systems for impurity-free and safe operation and determine the total particle burden with Cubis®️ II balances :
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Relying on a partner with a strong track record in key technologies (weighing, filtration, liquid handling, and water purification) will complement your in-house expertise, whether you are a medical device manufacturer, system integrator or engineering firm. We strive to help you to develop medical device solutions that meet the highest quality standards. Focus on your core business and let Sartorius serve you as a best-in-class supplier and one-stop solution provider.
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Collection of technical documentation to effectively limit interferences.
Discover the precision of Sartorius Cubis® II balances in ensuring accurate dosing rates for infusion pumps
Minimize risks in endotoxin testing with our smart pipetting solutions
Read this pipette selection checklist and find your perfect pipette
To remain competitive in the medical device market, you need to be able to reduce costs, while improving quality
What are 3D-printed medical devices and what are important quality checks in medical device manufacturing?
Ensuring product safety is top priority for pharmaceutical and medical device industries. Learn the basics of bioburden testing, regulations and common methods.
Many industries use lateral flow tests because they can detect a range of molecules. In this blog we talk about the nitrocellulose membranes that form the backbone of these tests.
Prior to sterilization, bioburden testing is used to determine the total number of viable microorganisms on all or part of a medical device surface. This is one of the most-used microbiological tests in the Medical Device industry.
As required by industrial standards such as ISO 11737-1, microorganisms should be suspended in the proper liquid, captured using membrane filtration and grown on a culture medium. Thus, using the right products and procedures to determine bioburden is essential and helps reduce risks to patient safety.
Discover our solutions for Microbial Enumeration Microbiological Testing for Medical Devices
Design of Experiments (DOE) is a data analytics method that helps you plan, conduct, analyze and interpret controlled tests to determine which factors exert influence over your product quality, stability, or other key process attributes. Rather than experimenting with one parameter at a time, DOE speeds up the process and helps you identify important interactions by manipulating multiple factors at the same time.
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The total solid content is defined as the mass of polymer per volume of latex, given in percent per weight (i.e. volume of particle phase to total volume of dispersion). A finished medical glove has a TSC of 100% since the substrate should not contain appreciable or significant amounts of water.
Moisture analyzers LMA200 can deliver TSC results within minutes. LMA200 helps optimize production of gloves and saves raw materials by applying the exact amount of latex your product needs.
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Nanotechnology solutions are commonly combined with medical devices to help drugs reach their target. Tangential flow filtration (TFF) enables simple diafiltration, while maintaining a constant sample volume and can easily be placed under sonication to prevent aggregation.
Watch our bubble point video to learn how you can easily verify the filter integrity.
Watch the Bubble Point Test Video
An ultra-microbalance with a scale interval of 0.1 μg and maximum weighing capacity offers a resolution in 21 million steps. In weight units, this is fine enough to measure a weight of 1 g of a total mass of 21 tons.
This high resolution provides ideal support for measuring the smallest sample weights below 1 mg within one part per thousand.
Read the White Paper: The Perfect Microbalance for Every Application
Professional training is a very good option to improve pipetting skills. Proper technique will increase the quality of results significantly, especially when working with viscous, volatile, or liquids with low surface tension. Ask your pipette provider if they offer training courses.
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According to Annex 1, it is recommended for manufacturers to employ a diverse range of methods including contact plates, settle plates, and volumetric air sampling. It is crucial not to solely rely on a single method and instead utilize a combination of these techniques.
Access the Article: EU GMP Annex 1—Impact on Air Monitoring Program for Medical Devices Manufacturers
To ensure the microbiological safety of sterile medical devices, manufacturers undertake various measures. Sterility testing is conducted following established procedures outlined in pharmacopoeias, such as USP <71> and Eur. Ph. 2.6.1, as a release testing to verify the absence of viable microorganisms.
Medical device manufacturers are responsible for understanding the bioburden of the device and validating the sterilization process, aiming for a low Sterility Assurance Level (SAL) with a minimal probability (10-6) of surviving microbes. Each batch must demonstrate sterility, and sterility assurance throughout the product's shelf life is ensured. Compliance with standards like ISO 11137 is essential for sterilization process validation.
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A product becomes an IVD when it is intended to be used for the examination of human specimens, including blood, urine, and tissue, in order to provide information for diagnostic, monitoring or compatibility purposes. IVD products can include reagents, instruments, and systems used to perform tests on samples for the detection, quantification, or measurement of specific analytes or biomarkers. The classification of a product as an IVD depends on its intended use and its compliance with applicable regulatory requirements.
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Sartorius' precision infusion pump testing solutions offer medical device manufacturers a range of benefits that ensure compliance with industry standards such as AAMI TIR 101, IEC 60601-2-24, FDA, MDR, and GMP. By utilizing our Cubis® II balances, manufacturers can achieve high resolution in flow rate and accuracy testing, which is critical for patient safety and device reliability. Visit our page to learn more about how our pump testing solutions can enhance your medical devices' performance and reliability.
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